mectron STARLIGHT UNO Maintenance Manual

Page 1

Û Use and maintenance manual

02150343 Manuale d‘uso e man. starlight uno

Rev. 02 del 11-05-2017

Reseller - Rivenditore - Wiederverkäufer - Revendeur - Revendedor

manufacturer: Mectron S.p.A. Via Loreto 15/A 16042 Carasco (Ge) Italy Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com e-mail: [email protected]

STARLIGHT UNO

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Summary

00.0 Introduction ......................................................................................................................33

00.1 Foreword ................................................................................................................33

00.2 Description of the equipment ..................................................................................33

00.3 Intended use ...........................................................................................................34

00.4 Safety requirements ...............................................................................................34

01.0 Identication data ............................................................................................................36

01.1 Identication data ...................................................................................................36

01.2 Identication plate of the charging unit ...................................................................36

01.3 Identication data of the starlight uno handpiece .................................................36

01.4 starlight uno battery module identication data ...............................................37

02.0 Testing .............................................................................................................................37

02.1 Testing of the equipment ........................................................................................37

03.0 Delivery............................................................................................................................37

03.1 Delivery of the equipment .......................................................................................37

03.2 List of material included in the standard supply ......................................................38

04.0 Installation .......................................................................................................................39

04.1 Safety requirements at the time of installation ........................................................39

04.2 Connecting the equipment ......................................................................................40

04.3 Description of the controls and signalling lamps ....................................................41

05.0 Battery .............................................................................................................................42

05.1 New battery - rst charging .....................................................................................42

05.2 Battery low signal ...................................................................................................42

05.3 Battery dead signal .................................................................................................42

05.4 Battery failed signal ................................................................................................43

05.5 Replacing the battery ..............................................................................................43

05.6 Safety requirements relating to the battery .............................................................43

06.0 Use ..................................................................................................................................44

06.1 Connecting the accessories ...................................................................................44

06.2 Safety requirements during use ..............................................................................45

06.3 Instructions for use .................................................................................................45

06.4 Measuring the light intensity ...................................................................................46

06.5 Safety protection .....................................................................................................46

07.0 Cleaning, disinfection and sterilisation ............................................................................47

07.1 Cleaning and disinfection of the handpiece and the charging unit .........................47

07.2 Cleaning and sterilisation of the optical protection .................................................48

07.2.1 Manual cleaning ............................................................................................ 48

07.2.2 Check cleaning .............................................................................................. 49

07.2.3 Drying .......................................................................................................... 49

07.2.4 Sterilisation ................................................................................................... 49

08.0 Disposal procedures and precautions .............................................................................50

09.0 Symbols ...........................................................................................................................51

10.0 Problem-solving ..............................................................................................................52

11.0 Technical specications ...................................................................................................53

11.1 Electromagnetic compatibility IEC/EN 60601-1-2 ...................................................54

12.0 Warranty ..........................................................................................................................60

starlight uno - manual of use and maintenance

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00.0 Introduction

00.1 Foreword

Before proceeding with the installation, use, maintenance or any other activities on the equipment please read this manual carefully.

Always keep this manual within easy reach.

Important: To avoid causing personal injuries or damage to property, read all the points concerning “Safety requirements” contained in this manual with particular attention. Depending on the level of risk involved, safety requirements are classed under the following indications:



WARNING (always referred to personal injury)



CAUTION (referred to possible damage to property)

The purpose of this manual is to ensure that operators are aware of the safety requirements, of the installation procedures and of the instructions for correct use and maintenance of the equipment. The user is not authorised to tamper with the equipment under any circumstances. If any problems are encountered, please contact a Mectron Service Centre. Any attempts on the part of the user or any unauthorised personnel to tamper with or alter the equipment will invalidate the warranty and release the Manufacturers from any liability in respect of any harm or damage to persons or property. The information and illustrations contained in this manual are updated as of the date of publication

indicated on the last page.

MECTRON are committed to continuous up-dating of their products, which may entail changes to components of the equipment. If there are any discrepancies between the descriptions contained in this manual and your equipment, please contact your dealer or the MECTRON After-Sale service

for explanations. Using this manual for purposes other than those relating to the installation, use and maintenance of

the equipment is strictly prohibited.

00.2 Description of the equipment

The starlight uno is an equipment for polymerising photo-hardening composites. The light source used is a very high-efciency monochromatic LED. Unlike traditional halogen lamps, therefore, all the light being emitted by the starlight uno is used to activate the camphorquinone photoinitiator. This means that it is possible to achieve excellent polymerisation performance levels using decidedly less power and without emitting heat. The device consists of an induction charging unit with a brightness meter and a handpiece powered by a rechargeable lithium-ion battery that can be removed and replaced directly by the user. The starlight uno can be used to operate in either of two emission modes:

- Constant intensity of emission - FAST (cycle lasting 10 seconds);

- Gradual intensity of emission - SLOW RISE (cycle lasting 20 seconds).

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00.3 Intended use

Polymerisation of photo-hardening dental materials with a photoinitiator that can be activated in the wavelength band comprised between 440 and 480 nm with a narrow peak at 460 nm. Although most composite materials are activated within this wavelength range, in case of uncertainty consult the specications of the composite material. This equipment may be used only in a dentist’s surgery or out-patient’s department where there are no inammable gases (anaesthetic mixtures, oxygen, etc.).

00.4 Safety requirements

Mectron will not accept any liability for direct or incidental personal injury or damage to property in the following cases: 1 If the equipment is used for purposes other than that for which it is intended. 2 If the equipment is not used in accordance with all the instructions and requirements described

in this manual.

3 If the wiring system in the room where the equipment is used does not comply with the

applicable standards and appropriate requirements.

4 If any assembly operations, extensions, settings, alterations or repairs have been carried out

by personnel not authorised by Mectron.

5 If the environmental conditions in which the device is kept and stored do not comply with the

requirements indicated in the chapter on technical specications.



CAUTION: No alterations to this device are permitted.



CAUTION: The wiring system of the premises on which this device is used must comply with

the applicable standards and requirements.



WARNING: Qualied and specialised personnel.

The device must be used exclusively by specialized personnel with proper medical culture; no

training activities are foreseen for the use of the device. The use of the device does not cause side

effects if it is used correctly.



WARNING: Intended use.

Use the equipment solely for the purpose for which it is intended (see point “00.3”). Failure to comply with this requirement could lead to serious harm to the patient and/or to the operator and/or damage to/failure of the equipment.



WARNING: Contraindications.

Do not use this equipment on patients tted with pace-makers or any other implantable electronic devices. This requirement applies equally to the operator.



WARNING: Point the beam of light directly at the material to be polymerised.

Do not use the beam of light on the gums or other soft tissues (if necessary these parts should be suitably shielded). The effect of the light should be limited to that part of the oral cavity to be clinically treated.



WARNING: Never point the beam of light towards the eyes.

The effect of the light should be limited to that part of the oral cavity to be clinically treated.



WARNING: Contraindications.

Do not use this equipment for patients who have a case history of positive reaction to stimulation by light e.g. urticaria solaris and/or porphyria, etc. or who are receiving treatment with photosensitising drugs. In all cases of possible risk consult a specialised physician.

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

WARNING: Contraindications.

Adopt strict safety measures for patients who have undergone cataract surgery and who are therefore particularly sensitive to light (e.g. protective goggles able to lter out blue light).



WARNING: Contraindications.

Patients who have a case history of diseases of the retina should consult their optician beforehand and be specically authorised to receive treatment with the starlight uno.



CAUTION: Photobiological safety of the curing lights and lamp systems IEC 62471.

According to the Standard IEC 62471, the device results in risk class 2 (moderate risk) concerning a retinal risk from blue light or thermal retinal risk. The following CAUTION indications are applied to the device package.

Risk Group 2

CAUTION. Possibly hazardous optical radiation emitted from this product. Do not stare at operating lamp. May be harmful to the eye

Product tested against IEC62471



WARNING: Cleaning, disinfection and sterilisation of new or repaired products.

Before treatment, all new or repaired products should be cleaned and disinfected and, if suitable for this treatment, autoclave sterilised following the instructions provided under point “07.0” strictly.



WARNING: Infection control.

For maximum safety of the patient and of the operator, before each treatment, clean and disinfect

the charging unit and the handpiece, cleane and sterilise the optical protection and replace the

protective sheath. Carefully follow the instructions provided in chapter “07.0”.



WARNING: Use only original Mectron accessories and spare parts.



WARNING: Checking the condition of the device before treatment.

Before each treatment always check that the equipment is in proper working order and that the accessories are efcient. Do not carry out the treatment if any problems are encountered in operating the equipment. If the problems concern the equipment contact an authorised technical

service centre.



WARNING: Risk of explosions.

The equipment cannot operate in environments where there are saturated atmospheres of ammable gases (anaesthetic mixtures, oxygen, etc.).



WARNING: Do not use the charging unit to recharge other types of batteries or other

equipment with rechargeable batteries.



CAUTION: Recharge the battery only with the Mectron charging unit (Fig.3 - Ref.A). Do

not attempt to recharge the battery using a generic battery charger. This entails a risk of

explosion and re.



CAUTION: In the case that the end user, when operating in his or her own dental facility or

clinic, must subject the electro-medical equipment and systems to periodical inspections in order to adhere to imposed requirements, test procedures that must be applied to electro-medical equipment and systems to evaluate safety must be performed in conformance with standard EN 62353 ‘Electro-medical devices - Periodical inspections and tests to be performed after repair

interventions on electro-medical devices’.

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01.0 Identication data

01.1 Identication data

An exact description of the model including the serial number of the equipment will make it easier for our After-Sale Service to respond quickly and efciently to your queries. Always provide the above information whenever you contact a Mectron Service Centre.

01.2 Identication plate of the charging unit

Each charging unit has an identication plate (Fig.1) on which the technical specications and the lot number are indicated. The identication plate is xed to the underside of the equipment. The

remaining data are contained in this manual (see point “11.0”).

STARLIGHT UNO

-CHARGER100-240 V - 50/60Hz. 15 VA

000000000

00000000

YYYY - MM - DD

manufacturer Mectron S.p.A. Via Loreto 15/A 16042 Carasco - GE - Italy

Rx only

made in Italy

Fig. 1

01.3 Identication data of the starlight uno handpiece

The serial number and some symbols are marked on each starlight uno handpiece (Fig.2).

YYYY

328R0 0000

starlight uno

Fig. 2

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01.4 starlight uno battery module identication data

The batch number and the technical specications are marked on each starlight uno battery module the batch number and the technical specications (Fig.3).

02.1 Testing of the equipment

00000000 00000000

YYYY-MM-DD

Li-Ion Battery 3,6V 0,8Ah

Fig. 3

02.0 Testing

All equipment manufactured by MECTRON is thoroughly checked and tested, including all

components.

During the testing procedure the components are subjected to a number of work cycles. The tests highlight any malfunctioning due to faulty components. This procedure ensures proper functioning and reliability of all components.

03.0 Delivery

03.1 Delivery of the equipment

The equipment contains electronic components that may be damaged by impacts even inside the packaging. Special care must therefore be taken for both transport and storage. All material shipped by MECTRON is checked at the time of shipment. The equipment is delivered properly protected and packaged. At the time of receipt of the equipment check it for possible transport damage. If any damage is found, make a complaint to the carrier.

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03.2 List of material included in the standard supply

1 starlight uno charging unit (Fig.4 - Ref.A). 1 starlight uno handpiece (Fig.4 - Ref.B).

1 Rechargeable lithium-ion battery module (Fig.4 - Ref.C). 1 Optical protection (Fig.4 - Ref.D). 50 Single use protective sheaths (Fig.4 - Ref.E). 1 Power supply cable for the charging unit (Fig.4 - Ref.F).

This equipment may vary at the time of promotional campaigns.

Fig. 4

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04.0 Installation

04.1 Safety requirements at the time of installation



WARNING: The wiring system of the premises where the equipment is installed and used must

comply with the applicable standards and the relevant electrical safety requirements.



WARNING: Risk of explosion. The equipment cannot operate in environments where there

are saturated atmospheres of ammable gases (anaesthetic mixtures, oxygen, etc.).



WARNING: Install the equipment in a place where it will be protected from shocks and from

accidental sprays of water or other liquids.



WARNING: Do not install the equipment above or in the vicinity of sources of heat. Make sure

that there is sufcient air circulating around the equipment.



WARNING: Do not insert metal objects into the handpiece of the charging unit (Fig.5 - Ref.B)

when the device is on.



CAUTION: The equipment is transportable, however it must be handled with care when it is

moved.



CAUTION: Do not expose the equipment to direct sunlight or to sources of UV light.



CAUTION: Always position the device in a way that the power plug is easily accessible at all

times; this is considered a insulation means.

starlight uno - manual of use and maintenance

Fig. 5

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04.2 Connecting the equipment

In order to make the equipment operational it is necessary to proceed as follows: 1 Place the charging unit on a at surface. 2 Plug the power cable (Fig.4 - Ref.D) into the connector on the rear of the equipment (Fig.5 -

Ref.A) and then into the power outlet. The green power LED should light up (Fig.7 - Ref.A).

3 Connect the battery module to the handpiece by tightening the nut of the battery module to the

handpiece as shown in Fig.6.



CAUTION: Make sure that the voltage and frequency of the power-supply line match the values

indicated on the identication label under the charging unit.



WARNING: Check the condition of the power cable regularly. If it is found to be damaged,

replace it with an original Mectron spare parts.



CAUTION: Always position the device in a way that the power plug is easily accessible at all

times; this is considered a insulation means.

Fig. 6

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04.3 Description of the controls and signalling lamps

Description of the controls (Fig. 4): Ref. A - Green power LED.

Function: This indicates that the charging unit is

powered up.

Ref. B - Green battery LED. Function This indicate that the starlight uno battery is

being charged.

Ref. C - test LED. Function Green: Indicates that the light intensity is

suitable for effective therapy.

Yellow: Indicates that the light intensity is

insufcient.

Ref. D - on/off button Function: This starts or stops a polymerisation cycle.

Fig. 7

Description of the acoustic and light signals of the handpiece (Table 1):

Function Button control Acoustic signal Light signal

FAST polymerisation

SLOW RISE polymerisation

Interruption of

exposure cycle

Battery low signal.

The residual

charge is sufcient for 6 cycles.

Battery dead

signal

Thermal protection signal

Brief pressure of on/off

button

Pressure of on/off

button for at least 2

seconds

Brief pressure of on/off

button during exposure

Pressure of on/off button for FAST or SLOW RISE polymerisation

1 beep on starting exposure 1 beep on completing exposure 10 sec.

1 beep when starting and 1 beep after

2 sec.

1 beep after 10 sec. of exposure 1 beep on completing exposure 20 sec.

1 beep

2 beeps on completing the exposure

cycle

2 beeps - No light emission

3 beeps at the end of FAST exposure

cycle or in the middle of SLOW RISE exposure cycle and functioning

interruption

Green LED steady on

Yellow LED steady on

Green and yellow LEDs ashing

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Description of light signals of the charging unit (Table 2):

Position of

Power LED Battery LED Test LED

ON OFF Not in place Charging unit powered ON ON In place Battery being recharged

the handpiece in the

charging unit

Function

ON OFF In place

ON OFF OFF Not in place Luminous ux absent.

ON OFF Yellow ON Not in place Luminous ux insufcient.

ON OFF Green ON Not in place

Recharging completed. Battery charged.

Luminous ux suitable for ef-

fective treatment.

05.0 Battery

The starlight uno is powered by a rechargeable lithium-ion battery already contained inside the handpiece, with no memory effect. The starlight uno is equipped with two microprocessors that check the battery continuously and maintain the optimum battery charging parameters. The handpiece may therefore be placed back

into the charging unit at the end of each treatment and left there, regardless of the charge of the

battery.

05.1 New battery - rst charging

NOTE: The battery of the starlight uno is supplied in a partly charged condition.

To charge the battery completely: 1 Insert the handpiece into its housing in the charging unit (Fig.5 - Ref.B). The green battery LED

will light up (Fig.7 - Ref.B).

2 The charging phase has been completed when the green battery LED extinguishes.

05.2 Battery low signal

When the charge of the battery becomes low, after frequent use of the starlight uno, the microprocessor will allow 6 more exposures to be carried out (FAST or SLOW RISE) without any need to recharge the battery. A battery low state is signalled at the end of each of these 6 cycles by means of 2 beeps. Once the 6 cycles have been completed, the handpiece enters a battery dead state (see point

“05.3”). Place the starlight uno back into the charging unit.

05.3 Battery dead signal

The battery of the starlight uno is dead if no light is emitted when the on/off button is pressed and at the same time an acoustic signal is heard (2 beeps). Recharge the battery: 1 Place the handpiece in its housing in the charging unit (Fig.5 - Ref.B). The green battery LED

will light up (Fig.7 - Ref.B).

2 When the green battery LED extinguishes the recharging phase has been completed.

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05.4 Battery failed signal

When the low battery handpiece is placed in the charging unit and the battery green LED on the charging unit remains off this means that there is a fault with the battery (Fig.7 - Ref.B). NOTE: This failure condition disables operation of the charging unit. To restore proper working conditions proceed as follows: 1 Remove the handpiece from the charging unit. 2 Cut off the power supply to the charging unit for a few seconds (disconnect the power cable) -

All the LEDs will extinguish.

3 Reconnect the cable of the charging unit. The green power LED will light up.

05.5 Replacing the battery

To replace the faulty battery, unscrew the nut of the battery module, remove it and replace it with a new one (Fig.6).

05.6 Safety requirements relating to the battery

The battery can cause damage to property and/or personal injuries such as burns if conducting materials such as jewellery, keys or beaded necklaces come into contact with the exposed terminals. The conducting material could close an electrical circuit (short circuit) and become very hot. Make a habit of handling the device with care, particularly if it is placed inside a pocket, bag or other container in which there are metal objects. In the case of contact of the terminals with metal objects and consequent short circuit, the lamp stops and it is necessary to reposition it on the battery charger to resume its operation.



WARNING: Do not insert metal objects into the handpiece of the charging unit (Fig.5 -

Ref.B) when the device is on.



WARNING: Keep the battery out of the reach of children.



CAUTION: Use only original Mectron batteries.



CAUTION: Recharge the battery only with the Mectron charging unit (Fig.3 - Ref.A). Do

not attempt to recharge the battery using a generic battery charger. This entails a risk of

explosion and re.



CAUTION: The battery should be recycled or disposed of in the appropriate manner in accordance with the law. The battery should not be thrown away with normal waste. The user will be liable for any damages caused by improper disposal of the battery.



CAUTION: Do not use the battery for purposes other than those for which it is intended.



CAUTION: Do not open, pierce or crush the battery. It contains toxic substances.



CAUTION: Do not burn the battery or expose it to a high temperature. There is a risk of explosion.



CAUTION: Do not short-circuit the battery terminals. This could cause burns and re.

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06.0 Use

06.1 Connecting the accessories



WARNING: Check the condition of the device before the treatment.

Before each treatment, always make sure that the equipment is working properly and check the efciency of the accessories. If any improper functioning is noted, do not proceed with the treatment. If the problem concerns the equipment contact an authorised technical assistance

centre.



WARNING: Infections control.

For maximum safety of the patient and of the operator, before each treatment, clean and disinfect

the charging unit and the handpiece, cleanse and sterilise the optical protection and replace the

protective sheath. Carefully follow the instructions provided in chapter “07.0”.



WARNING: The protective sheaths are single use. Each protective sheath must be used for one application only on a single patient.

Before using the starlight uno, the following are necessary: 1 Ensure the battery module is correctly connected to the handpiece; 2 Insert the single use protective sheath onto the handpiece (Fig.8 - Ref.A); 3 Fix the optical protection onto the handpiece (Fig.8 - Ref.B).

Fig. 8

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06.2 Safety requirements during use



WARNING: Never point the beam of light in the direction of the eyes.



WARNING: Before each cycle of exposure always make sure that the optical protection

has been tted onto the handpiece.



WARNING: Point the beam of light directly onto the material to be polymerised.

Do not subject the gum or other soft tissues to the beam of light (shield these parts suitably if necessary). The effect of the light should be limited to the oral cavity and in particular to the sector requiring clinical treatment.



WARNING: Do not insert metal objects into the handpiece of the charging unit (Fig.5 - Ref.B) when the device is on.



CAUTION: During the rst few seconds of exposure avoid contact of the tip with the

material to be polymerised.

Deposits of composite material adhering to and polymerised to the tip terminal surface lower the amount of light transmitted and will therefore prejudice subsequent polymerisation operations.

06.3 Instructions for use

The starlight uno can be used in two different modes:

- FAST: exposure time of 10 seconds at the maximum light intensity.

- SLOW RISE: exposure time 20 seconds with a gradual increase of the light intensity during the

rst 3 seconds up to the maximum intensity.

Selecting the FAST exposure mode.

- To start the FAST exposure cycle press the on/off button on the handpiece briey (Fig.7 -

Ref.D). An acoustic signal will be heard (1 beep) and the green LED on the handpiece will light

up.

- After 10 seconds an acoustic signal will be heard (1 beep) and the green LED on the

handpiece will go out. The FAST cycle has been completed.

Selecting the SLOW RISE exposure mode.

- To start the SLOW RISE exposure cycle hold the on/off button on the handpiece down for

2 seconds (Fig.7 - Ref.D). At the start an acoustic signal will be heard and after 2 seconds another acoustic signal to conrm the SLOW RISE cycle beginning. The yellow LED on the handpiece will light up.

- After 10 seconds an acoustic signal will be heard (1 beep).

- After 20 seconds an acoustic signal will be heard (1 beep) ) and the yellow LED on the

handpiece will go out. The SLOW RISE cycle has been completed.

After the end of the treatment, remove the protective sheath used and place the starlight uno

handpiece back into the charging unit (Fig.5 - Ref.B).

NOTE: Interrupting the cycle. Both in the FAST and in the SLOW RISE mode, the exposure cycle can be broken off at any time by pressing the on/off button on the handpiece (Fig.7 - Ref.D).

NOTE: Additional exposure cycles. At the end of any exposure cycle, it is possible to carry out one or more additional cycles by pressing the on/off button on the handpiece again each time (Fig.7 - Ref.D).

For a quick guide to the signalling, see Tables 1 and 2.

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06.4 Measuring the light intensity

To determine whether the light intensity is sufcient: 1 Place the tip (Fig.7 - Ref.A) at on the surface of the light-intensity sensor without pressing it

(Fig.7 - Ref.B);

2 Press the on/off button (Fig.7 - Ref.C) to switch on the lamp.

The test LED (Fig.7 - Ref.D) will indicate the working luminous ux measured:

- Green = luminous ux suitable for effective treatment;

- Yellow = luminous ux insufcient.



CAUTION: If the working luminous ux is not sufcient, do not proceed with the treatment on the patient and carry out the following checks: 1 Check that the tip is not dirty;

2 Clean the tip (see point 7.1 - Cleaning and disinfecting the handpiece and the charging unit);

If these measures do not lead to improved performance, place the device out of commission (by disconnecting it from the mains) and make sure that it cannot be started by unauthorised persons. Any repair work on the device should be carried out by an authorised Mectron service centre.

06.5 Safety protection

In the event of extremely heady duty use, with long and repeated exposure cycles, a thermal protection device is triggered automatically. An acoustic signal (3 beeps) will be heard. This protection device will temporarily prevent use of the lamp for a few minutes. The yellow and green LEDs ash.

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07.0 Cleaning, disinfection and sterilisation

This table is purely indicative. For the complete cleaning, disinfecting and sterilization procedures of the individual parts, refer to the paragraphs indicated in the table.



CAUTION: All the phases indicated in the following table must be performed, avoiding using methods not referred to in that table.



WARNING: The protective sheaths are single use. Each protective sheath must be used for one application only on a single patient.

Phase Paragraph Procedure Handpiece

Manual cleaning with

I 07.1

II 07.2.1

III 07.2.2 Check cleaning X

IV 07.2.3 Drying X

V 07.2.4 Sterilisation X

detergent solution and disinfecting agent

Immersion into enzymatic detergent

X X

Charging

unit

Optical

protection

07.1 Cleaning and disinfection of the handpiece and the charging unit



WARNING: Switch off the charging unit.

Before carrying out any cleaning and disinfection, disconnect the charging unit from the mains power supply.

PREPARATION

- Remove the handpiece from the charging unit;

- Remove the optical protection from the handpiece;

- Remove the protective sheath from the handpiece.

MATERIALS NECESSARY

- Clean, soft cloths with low ber-release;

- Detergent solution (pH 6-9);

- Demineralised water;

- Disinfectant agent (Glutaraldehyde, Ghlorhexidine gluconate or Isopropyl alcohol 70%).

CLEANING METHOD

1 Clean the surface of the charging unit and the handpiece with a clean, soft and low bre

release cloth, dampened with a cleaning solution (pH 6-9) prepared according to the

manufacturer’s instructions;

2 Clean the surface of the charging unit and the handpiece with a clean, soft and low bre

release cloth, dampened with demineralised water to remove all residues of the cleaning

solution;

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3 Dry the surface of the charging unit and the handpiece with a clean, soft and low bre release

cloth;

4 If you intend to disinfect, spray the disinfecting agent onto a clean, soft and low bre release

cloth and clean the surface of the charging unit and of the handpiece.



CAUTION: Do not use as disinfecting agents:

• Very alkaline products (pH > 9);

• Products containing sodium hypochlorite;

• Products containing hydrogen peroxide;

• Products containing abrasive substances;

• Acetone;

• Methylethylketone. as they can discolour and/or damage the plastic materials.



CAUTION: Contact of liquid with the lamp terminals can cause damage and therefore voids the warranty.



CAUTION: Contact of liquid with the LED causes damage and therefore voids the warranty.



CAUTION: Do not spray liquid directly onto the surface of the charging unit and/or of the

handpiece.



CAUTION: The casing of the charging unit and/or the handpiece are not protected against the entry of liquids.



CAUTION: The charging unit and the handpiece should not be sterilised.

07.2 Cleaning and sterilisation of the optical protection

07.2.1 Manual cleaning



CAUTION: The only part of the device that can be sterilised is the optical protection. MATERIALS NECESSARY

- Clean, soft cloths with low ber-release;

- Enzymatic detergent at pH 6-9;

- Water;

- Container for immersion in the enzymatic liquid;

- Brush with soft nylon bristles.



CAUTION: Do not use sharp-edged objects to clean the optical protection.

CLEANING METHOD

1 Prepare an enzymatic detergent solution with pH 6-9, as per the instructions of the

manufacturer;



CAUTION: Once used, dispose of the enzymatic detergent correctly, do not recycle it. 2 Place the optical protection horizontally in a clean container and add enzymatic detergent

solution until the optical protection is covered completely; 3 Let the optical protection soak for 10 minutes at 40°C ±2°C; 4 During immersion in the enzymatic solution, delicately brush the surface of the optical

protection using the brush with soft nylon bristles to eliminate all traces of visible dirt; 5 Delicately brush the surface of the optical protection under running water using the brush with

soft nylon bristles;

starlight uno - manual of use and maintenance

Page 19



CAUTION: Do not use as disinfecting agents:

• Very alkaline products (pH > 9);

• Products containing sodium hypochlorite;

• Products containing hydrogen peroxide;

• Products containing abrasive substances;

• Acetone;

• Methylethylketone. as they can discolour and/or damage the plastic materials

07.2.2 Check cleaning

Once the cleaning operations have been completed, visually inspect the optical protection under an adequate source of light, if necessary using a magnifying glass 2.5X, paying attention to the details that could conceal dirt residue (threading, cavities, grooves) and, if necessary, repeat the cleaning cycle if dirt is still visible. Finally, check the integrity of those parts and those elements that could

have deteriorated during use.

07.2.3 Drying

Thoroughly dry all parts of the optical protection with a soft low bre release cloth, possibly blowing with compressed air.

07.2.4 Sterilisation



CAUTION: Carry out sterilisation only in a steam autoclave. Do not use any other

sterilisation procedures (dry heat, radiation, ethylene oxide, gas, low-temperature plasma, etc.).



CAUTION: The optical protections are made from materials able to withstand a maximum

temperature of 135°C for a maximum period of 20 minutes.



WARNING: Infections control - Sterilisable parts.

To avoid infection by bacteria or viruses, carefully remove any remaining organic dirt prior to

sterilisation.

STERILISATION PROCEDURE

Seal the optical protection individually in a disposable bag for sterilisation and proceed with the

process of sterilisation in a steam autoclave. The sterilization process, in a steam autoclave, guarantees SAL 10

indicated below:

- Type of cycle: 3 times Pre-vacum (pressione min. 60 mBar).

- Minimum sterilisation temperature: 132 °C (interval 0 °C ÷ +3 °C).

- Minimum sterilisation time: 4 minutes.

- Minimum drying time: 10 minutes.

All the stages of sterilisation must be carried out by the operator in accordance with UNI EN ISO 17665-1:2007, UNI EN ISO 556-1:2002 and ANSI/AAMI ST 46:2002.

-6

by setting the parameters

starlight uno - manual of use and maintenance

Page 20

08.0 Disposal procedures and precautions



- This equipment must be disposed of and treated as waste requiring separate collection;

- At the end of the life-cycle of this equipment, the purchaser is entitled to return the equipment

- Failure to comply with the foregoing points may entail punishment in accordance with Directive

Treat the following items as hospital waste:

- Optical protection, when worn or broken;

- Protective sheath, at the end of each application.

CAUTION: This device contains a LITHIUM-ION battery. The battery must be disposed

of and treated as waste requiring separate collection;

to the dealer supplying new equipment. Instructions for disposal are available from Mectron

S.p.A.;

about waste of electrical and electronic equipment WEEE.



WARNING: Hospital waste.

starlight uno - manual of use and maintenance

Page 21

09.0 Symbols



CAUTION, See instructions for



use

Consult operating instructions Lot number

Type “B” applied part in conformity with technical norm IEC/EN

60601-1

Manufacturer Date of manufacture

Class II apparatus

Alternate current

Non sterile

Serial number

Catalogue number

Temperature limitation - transport and storage conditions

Humidity limitation - transport and

storage conditions

Atmospheric pressure limitation - transport and storage conditions

Can be sterilised in autoclave

up to a maximum temperature of

135 °C

Symbol ISO 7010-W001 Generic CAUTION symbol

The device and its accessories

must not be disposed of or treated as solid urban waste

Do not re-use

Nemko Mark

Conformity to norms UL - CSA

Device manufactured in conformity with directive 93/42/EEC including technical norms EN 60601-1 and EN 60601-1-2.

starlight uno - manual of use and maintenance

Page 22

10.0 Problem-solving

If the equipment appears not to be working correctly, read the instructions again and then check the following table.

PROBLEM POSSIBLE CAUSE SOLUTION

The charging unit does not

switch on (none of the LEDs will light up).

There is no beam of light when the on/off button of the

starlight uno is pressed and an acoustic signal is heard (2

beeps).

An acoustic signal is heard ad

the end of the exposure cycle (2 beeps).

An acoustic signal (3 beeps)

is heard during the exposure

cycle and at the end of the cycle starlight uno will not enable any further treatment to be carried out.

The power cable is not connected correctly.

The power cable is faulty.

The charging unit is out of order.

Battery dead.

Battery low.

The thermal protection has

been activated.

Connect the cable both to the charging unit and to the wall socket.

Replace the power cable.

Contact an authorised

MECTRON technical

assistance centre.

Recharge the battery. See

point “05.3”.

Recharge the battery. See

point “05.2”.

It will be possible to use the equipment only after it has cooled down.

The polymerisation is insufcient.

An acoustic signal is heard (4

beeps) and there is no beam

of light.

The terminal surface of the tip is soiled.

Hardware failure. Contact an authorised

starlight uno - manual of use and maintenance

See point “07.5”.

MECTRON technical

assistance centre.

Page 23

11.0 Technical specications

This equipment complies with Directive 93/42/EEC: Class I Class according to IEC/EN 60601-1: II

Applied part type B (Tip)

IP 20 (Charging unit) IP 20 (Handpiece)

Essential performances: According to Standard IEC 80601-2-60 the device

does not have essential performances

Charging station: Model starlight uno -CHARGER-

Charging station power supply requirements: 100-240 V~ 50/60 Hz 15 VA

Power supply of starlight uno handpiece: Rechargeable Lithium-ion battery.

Manufacturer: Panasonic. Model: UR-14500. Nominal Voltage: 3.6 V Nominal capacity (Typical): 840 mAh

Handpiece for intermittent operation: 60” ON 60” OFF Max 3 times running

Source of light: High luminosity LED with opti.

Dominant wave length: 440 - 465 nm LED in class

2 (IEC 62471) retinal risk from blue light or thermal retinal risk.

Esposure: FAST: Exposure time 10 seconds

- Acoustic signals indicating start and end of

exposure.

SLOW RISE: Exposure time 20 seconds

- Acoustic signal at the start, after 10 seconds and

at the end of the 20 seconds.

The cycles can be stopped or repeated at any

time.

Time required to recharge a dead battery: About 4 hours. Ch: CC-CV 200mA ±10% 4,20V ±1%

Operating conditions: from 10 °C to 35 °C Relative Humidity from 45% to 85% Air pressure P: 800 hPa/1060 hPa

Transport and storage conditions: from -20 °C to 40 °C Relative Humidity from 45% to 85% Air pressure P: 500 hPa/1060 hPa

Weights and dimensions: Charging unit: Weight 108 g

93 x 93 x 40 mm starlight uno handpiece: Weight 77 g L 190 mm Max. Ø 21 mm

starlight uno - manual of use and maintenance

Page 24

11.1 Electromagnetic compatibility IEC/EN 60601-1-2



WARNING: The device requires specic EMC precautions and must be installed and started up

in accordance with the EMC information given in this paragraph.



WARNING: Portable and mobile radio communication appliances may affect the correct

functioning of the device.

Guidance and manufacturer’s declaration - Electromagnetic emissions

The starlight uno is intended for use in the electromagnetic environment specied below. The customer or the user of the starlight uno should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - Guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage uctuations / icker

emissions

IEC 61000-3-3

Group 1 The starlight uno uses RF energy only for its internal

function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B The starlight uno is suitable for use in all establishments, includ-

ing domestic establishments and those directly connected to the

Class A

Complies

public low-voltage power supply network that supplies buildings

used for domestic purposes.

starlight uno - manual of use and maintenance

Page 25

Guidance and manufacturer’s declaration - Elettromagnetic immunity

Enclosure port

The starlight uno device is designed to work in the electromagnetic environment specied below. The client or user of the starlight uno device should always make sure that it is used only in such

environment.

Phenomenon

Electrostatic discharge (ESD)

Basic EMC

standard or test

Immunity test levels

method

IEC 61000-4-2 ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Floors must be wood, concrete or ceramic. If the

oor is lined with synthetic

Electromagnetic

environment - Guidance

materials, the relative humidity should be at least 30 %

Radiated RF EM

elds

IEC 61000-4-3 3 V/m

80 MHz - 2,7 GHz 80 % AM at 1 kHz

Portable or mobile RF communication device must not be used in close proximity of the product, including its cables, except when these respect the distances of separation recommended and calculated from the equation applicable to the frequency of the transmitter.

Rated power frequency

magnetic elds

IEC 61000-4-8 30 A/m

50 Hz or 60 Hz

d) e)

Grid frequency magnetic

elds should have levels

characteristic of a typical commercial or hospital environment.

The interface between the PATIENT physiological signal simulation, if used, and the starlight uno shall be located within 0, 1 m of

the vertical plane of the uniform eld area in one orientation of the starlight uno.

starlight uno that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the

frequency of reception. Testing may be performed at other modulation frequencies identied by the RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL PERFORMANCE of an intentional receiver when an ambient

signal is in the passband. It is understood that the receiver might not achieve normal reception during the test.

Testing may be performed at other modulation frequencies identied by the RISK MANAGEMENT PROCESS.

Applies only to starlight uno with magnetically sensitive components or circuitry.

During the test, the starlight uno may be powered at any NOMINAL input voltage, but with the same frequency as the test

signal.

Before modulation is applied.

This test level assumes a minimum distance between the starlight uno and sources of power frequency magnetic eld of at least

15 cm. If the RISK ANALYSIS shows that the starlight uno will be used close than 15 cm to sources of power frequency magnetic eld, the IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum expected distance.

starlight uno - manual of use and maintenance

Page 26

Guidance and manufacturer’s declaration - Elettromagnetic immunity

Input a.c. power port

The starlight uno device is designed to work in the electromagnetic environment specied below. The client or user of the starlight uno device should always make sure that it is used only in such

environment.

Phenomenon

Electrical fast transients / bursts

a) l) o)

Basic EMC standard

or test method

Immunity test levels

IEC 61000-4-4 ±2 kV contact

100 KHz repetition frequency

The quality of the power

supply should be that of a typical commercial or hospital

Electromagnetic

environment - Guidance

environment.

Surges Line-to-line

a) b) j) o)

IEC 61000-4-5 ± 0,5 kV, ± 1 kV The quality of the power

supply should be that of a typical commercial or hospital environment.

Surges Line-to-ground

b) j) k) o)

IEC 61000-4-5 ± 0,5 kV, ± 1 kV, ± 2kV The quality of the power

supply should be that of a typical commercial or hospital environment.

Conducted disturbances induce

by RF elds

c) d) o)

IEC 61000-4-6 3 V

0,15 MHz - 80 MHz

6 V

in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 KHz

Portable or mobile RF communication device must not be used in close proximity of

the product, including its cables, except when these respect the distances of separation recommended and calculated from the equation applicable to the frequency of the transmitter.

Voltage dips

f) p) r)

IEC 61000-4-11 0% UT; 0,5 cycle

At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

; 1 cycle

0 % U

The quality of the power

supply should be that of a typical commercial or hospital environment.

and

70 % UT; 25/30 cycles

Single phase: at 0°

Voltage interruptions

f) i) o) r)

IEC 61000-4-11 0% UT; 250/300 cycle

The quality of the power

supply should be that of a typical commercial or hospital environment.

The test may be performed at any one power input voltage within the starlight uno RATED voltage range. If the starlight uno is

tested at one power input voltage, it is not necessary to re-test at additional voltages.

All starlight uno cables are attached during the test.

Calibration for current injection clamps shall be performed in a 150 Ω system.

If the frequency stepping skips over an ISM or amateur band, as applicable, an additional test frequency shall be used in the ISM

or amateur radio band. This applies to each ISM and amateur radio band within the specied frequency range.

Testing may be performed at other modulation frequencies identied by the RISK MANAGEMENT PROCESS.

starlight uno with a d.c. power input intended for use with a.c.-to-d.c. converters shall be tested using a converter that meets the

specications of the MANUFACTURER of the starlight uno. The IMMUNITY TEST LEVELS are applied to the a.c. power input of

the converter .

Applicable only to starlight uno connected to single-phase a.c. mains.

E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz.

starlight uno with RATED input current greater than 16 A / phase shall be interrupted once for 250/300 cycles at any angle and at

all phases at the same time (if applicable). starlight uno with battery backup shall resume line power operation after the test. For

starlight uno with RATED input current not exceeding 16 A, all phases shall be interrupted simultaneously.

starlight uno - manual of use and maintenance

Page 27

starlight uno that do not have a surge protection device in the primary power circuit may be tested only at ± 2 kV line(s) to earth

and ± 1 kV line(s) to line(s).

Not applicable to CLASS II starlight uno.

Direct coupling shall be used.

r.m .s. , before modulation is applied.

The ISM (industrial scientic and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to

13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0, 15 MHz and 80

MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.

Applicable to starlight uno with RATED input current less than or equal to 16 A / phase and starlight uno with RATED input

current greater than 16 A / phase.

Applicable to starlight uno with RATED input current less than or equal to 16 A / phase.

At some phase angles, applying this test to starlight uno with transformer mains power input might cause an overcurrent

protection device to open. This can occur due to magnetic ux saturation of the transformer core after the voltage dip. If this

occurs, the starlight uno shall provide BASIC SAFETY during and after the test.

For starlight uno that have multiple voltage settings or auto ranging voltage capability, the test shall be performed at the

minimum and maximum RATED input voltage. starlight uno with a RATED input voltage range of less than 25 % of the highest RATED input voltage shall be tested at one RATED input voltage within the range.

Guidance and manufacturer’s declaration - Elettromagnetic immunity

Patient coupling port

The starlight uno device is designed to work in the electromagnetic environment specied below. The client or user of the starlight uno device should always make sure that it is used only in such

environment.

Phenomenon

Electrostatic discharge (ESD)

Basic EMC

standard or test

method

IEC 61000-4-2 ±8 kV contact

Immunity test

levels

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electromagnetic

environment - Guidance

Floors must be wood,

concrete or ceramic. If the oor is lined

with synthetic materials, the relative humidity should be at least 30 %

Conducted disturbances induce

by RF elds

IEC 61000-4-6 3 V

0,15 MHz - 80 MHz

6 V

in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 KHz

The following apply:

- All PATIENT-COUPLED cables shall be tested, either individually or bundled

- PATIENT-COUPLED cables shall be tested using a current clamp unless a current clamp is not suitable. In cases where a current

clamp is not suitable, an EM clamp shall be used.

- No intentional decoupling device shall be used between the injection point and the PATIENT COUPLING POINT in any case.

- Testing may be performed at other modulation frequencies identied by the RISK MANAGEMENT PROCESS.

- Tubes that are intentionally lled with conductive liquids and intended to be connected to a PATIENT shall be considered to be PATIENT-COUPLED cables.

- If the frequency stepping skips over an ISM or amateur radio band, as applicable, an additional test frequency shall be used in

the ISM or amateur radio band. This applies to each ISM and amateur radio band within the specied frequency range.

- The ISM (industrial, scientic and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0, 15 MHz and 80

MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18, 17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29, 7 MHz and 50,0 MHz to 54,0 MHz.

r.m.s., before modulation is applied

Discharges shall be applied with no connection to an articial hand and no connection to PATIENT simulation. PATIENT

simulation may be connected after the test as needed in order to verify BASIC SAFETY and ESSENTIAL PERFORMANCE.

starlight uno - manual of use and maintenance

Page 28

Guidance and manufacturer’s declaration - Elettromagnetic immunity

Signal input / output parts port

The starlight uno device is designed to work in the electromagnetic environment specied below. The client or user of the starlight uno device should always make sure that it is used only in such

environment.

Phenomenon

Electrostatic discharge (ESD)

Basic EMC

standard or test

Immunity test levels

method

IEC 61000-4-2 ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electromagnetic

environment - Guidance

Floors must be wood, concrete or ceramic. If the

oor is lined with synthetic

materials, the relative humidity should be at least 30 %

Electrical fast transients / bursts

b) f)

IEC 61000-4-4 ±1 kV contact

100 KHz repetition frequency

The quality of the power

supply should be that of a typical commercial or hospital environment.

Surges Line-to-ground

IEC 61000-4-5 ± 2kV The quality of the power

supply should be that of a typical commercial or hospital environment.

Conducted disturbances induce by RF

b) d) g)

elds

IEC 61000-4-6 3 V

0,15 MHz - 80 MHz

6 V

in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 KHz

This test applies only to output lines intended to connect directly to outdoor cables.

SIP/SOPS whose maximum cable length is less than 3 m in length are excluded.

Testing may be performed at other modulation frequencies identied by the RISK MANAGEMENT PROCESS.

Calibration for current injection clamps shall be performed in a 150 Ω system.

Connectors shall be tested per 8.3.2 and Table 4 of IEC 61000-4-2:2008. For insulated connector shells, perform air discharge

testing to the connector shell and the pins using the rounded tip nger of the ESD generator, with the exception that the only connector pins that are tested are those that can be contacted or touched, under conditions of INTENDED USE, by the standard test nger shown in Figure 6 of the general standard, applied in a bent or straight position.

Capacitive coupling shall be used.

If the frequency stepping skips over an ISM or amateur radio band, as applicable, an additional test frequency shall be used in

the ISM or amateur radio band. This applies to each ISM and amateur radio band within the specied frequency range.

r.m.s., before modulation is applied.

The ISM (industrial, scientic and medical) bands between 150 kHz and 80 MHz are 6, 765 MHz to 6,795 MHz; 13,553 MHz to

13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0, 15 MHz and 80

starlight uno - manual of use and maintenance

Page 29

Test specifications for enclosure port immunity to RF wireless communications

equipment

The starlight uno device is designed to work in an electromagnetic environment in which RF radiated disturbances are kept under control. The purchaser or user of the starlight uno device

can contribute to prevent electromagnetic interference by ensuring a minimum distance between the RF mobile and cordless communication device (transmitters) and the starlight uno device, as recommended below, in relation to the maximum output power of the radio-communication devices.

Test

frequency

(MHz)

385 380 - 390

450 430 - 470

710

780

810

870

930

Band

(MHz)

TETRA 400

GMRS 460, FRS

704 - 787 LTE Band 13, 17

GSM 800/900,

800 - 960

TETRA 800, iDEN

820, CDMA 850,

LTE Band 5

Service

460

Modulation

Pulse modulation

18 Hz

± 5 kHz deviation

1 kHz sine

Pulse modulation

217 Hz

Pulse modulation

18 Hz

Maximum

power

(W)

1,8 0,3 27

2 0,3 28

0,2 0,3 9745

2 0,3 28

Distance

(m)

Immunity

test level

(V/m)

1720

1845

1970

2450 2400 - 2570

5420

5785

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the starlight uno may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

For some services, only the uplink frequencies are included.

The carrier shall be modulated using a 50 % duty cycle square wave signal.

As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual

modulation, it would be worst case.



WARNING: Portable RF communications equipment (including peripherals such as antenna

1700 - 1990

5100 - 5800 WLAN 802.11 a/n

GSM 1800; CDMA

1900; GSM 1900;

DECT; LTE Band 1,

3, 4, 25; UMTS

Bluetooth, WLAN,

802.11 b/g/n,

RFID 2450, LTE

Band 7

Pulse modulation

217 Hz

Pulse modulation

217 Hz

Pulse modulation

217 Hz

2 0,3 28

0,2 0,3 95500

cables and external antennas) should be used no closer than 30 cm ( 12 inches) to any part of the starlight uno device, including cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

starlight uno - manual of use and maintenance

Page 30

12.0 Warranty

Before being placed on the market, all Mectron equipment undergoes a thorough nal check to ensure that it is are in proper working order. Mectron warrant their products, purchased brand-new from authorised Mectron dealers or importers, free from material or manufacturing defects for a period of 3 (THREE) years for the handpiece and 1 (ONE) years for the battery module from the date of purchase. Throughout the warranty period, Mectron undertake to repair (or, at their sole discretion, to replace) free of charge any parts that, in their opinion, are faulty.

Complete replacement of Mectron products is excluded.

Mectron cannot accept any liability for direct or incidental damage or personal injury in the following cases:

- If the equipment is used for purposes other than that for which it is intended.

- If the equipment is not used in accordance with all the instructions and requirements described

in this manual.

- If the wiring system in the room where the equipment is used does not comply with the applicable standards and appropriate requirements.

- If any assembly operations, extensions, settings, alterations or repairs have been carried out by personnel not authorised by Mectron.

- If the environmental conditions in which the device is kept and stored do not comply with the requirements indicated in the chapter on technical specications.

Accidental damages due to transport, incorrect use or carelessness or to connection to power

supplies other than as envisaged and damage to the signalling lamps, handpieces and all

accessories are excluded from the warranty. The warranty will no longer apply if the equipment has been tampered with or repaired by

unauthorised personnel.

CAUTION

The warranty is valid only if the warranty slip enclosed with the product has been completed in full and returned to us or, if appropriate, to your Mectron dealer or importer within 20 (TWENTY) DAYS from the date of purchase, as proven by the consignment note/invoice issued by the dealer/

importer.

In order to benet from the warranty service, the customer must return the equipment to be repaired to the Mectron dealer/importer from which it was purchased, at his own expense. The equipment should be returned suitably packed (possibly in its original packing material), accompanied by all the accessories and by the following information:

a) Owner’s details, including his telephone number. b) Details of the dealer/importer. c) Photocopy of the consignment note/purchase invoice of the equipment issued to the owner and

indicating, in addition to the date, also the name of the equipment and its serial number.

d) A description of the problem.

Transport and any damages caused during transport are not covered by the warranty. In the event of failures due to accidents or improper use, or if the warranty has lapsed, repairs to Mectron products will be charged on the basis of the actual cost of the materials and labour required for such repairs.

starlight uno - manual of use and maintenance

Page 31

The indications that appear in this publication are not binding and can be modied without fore-notice. The Italian version of this manual is the original document from which its translations have been obtained. In case of any discrepancy,

the Italian version will have pertinence.

Texts, images, and graphics of this manual are property of Mectron S.p.A., Carasco, Italy. All rights reserved. The contents cannot be copied, distributed, changed, or made available to third parties without the written approval of Mectron

S.p.A.

starlight uno - manual of use and maintenance